Download Duopa®, carbidopa/levodopa enteral infusion, dru403

Medication Policy Manual
Policy No: dru403
Topic: Duopa®, carbidopa/levodopa enteral infusion Date of Origin: July 10, 2015
Committee Approval Date: July 15, 2016
Next Review Date: July 2017
Effective Date: August 1, 2016
IMPORTANT REMINDER
This Medication Policy has been developed through consideration of medical necessity,
generally accepted standards of medical practice, and review of medical literature and
government approval status.
Benefit determinations should be based in all cases on the applicable contract language. To the
extent there are any conflicts between these guidelines and the contract language, the contract
language will control.
The purpose of Medication Policy is to provide a guide to coverage. Medication Policy is not
intended to dictate to providers how to practice medicine. Providers are expected to exercise
their medical judgment in providing the most appropriate care.
Description
Carbidopa/levodopa (Duopa) is a self-administered enteral infusion indicated for the treatment of
motor fluctuations in patients with advanced idiopathic Parkinson’s disease. It is administered as
a continuous 16-hour daily infusion into the small intestine through a percutaneous endoscopic
gastrostomy-jejunostomy (PEG-J) tube using a portable infusion pump.
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Policy/Criteria
I.
Most contracts require prior authorization approval of carbidopa/levodopa enteral
infusion prior to coverage. Carbidopa/levodopa enteral infusion may be considered
medically necessary when criteria A, B, C, and D below are met:
A.
A diagnosis of idiopathic Parkinson’s disease when established by or in
consultation with a specialist in neurology.
AND
B.
There is clinical documentation that the patient is experiencing disabling motor
fluctuations (“off time”) of greater than or equal to 6 hours per day while on a
levodopa-containing product.
AND
C.
Documentation that adequate trials of at least THREE adjunctive therapies from
three different classes in combination with a levodopa-containing product, as
specified in criteria a, b, AND c below, were either ineffective, not tolerated, or
contraindicated:
a.
Entacapone OR tolcapone (Tasmar).
AND
b.
AND
D.
II.
III.
A dopamine agonist (such as pramipexole, ropinirole, or apomorphine).
(See Appendix 1)
AND
c.
Selegiline OR rasagiline mesylate (Azilect).
Patient is responsive to levodopa therapy as supported by defined “on” periods of
any duration when Parkinsonism symptoms are controlled while on a levodopacontaining product.
Administration, Quantity Limitations, and Authorization Period
A.
OmedaRx considers carbidopa/levodopa enteral infusion to be a selfadministered medication.
B.
When prior authorization is approved, carbidopa/levodopa enteral infusion may
be authorized in quantities of up to 30 cassettes per month.
C.
Authorization shall be reviewed at least every six months to confirm that current
medical necessity criteria are met and that the medication is effective.
Carbidopa/levodopa enteral infusion is considered investigational when used for all
other conditions, including but not limited to:
A.
Secondary Parkinsonism (e.g. drug-induced, neurodegenerative, postencephalitic)
B.
Atypical parkinsonian syndrome
C.
Restless leg syndrome
D.
Essential tremor
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Position Statement
-
Carbidopa/levodopa enteral infusion (Duopa) has been shown to be effective in reducing
motor fluctuations in patients with advanced idiopathic Parkinson’s disease (PD);
however, significant safety concerns undermine its net health benefit relative to oral and
topical PD medications which have a more favorable safety profile.
-
Carbidopa/levodopa enteral infusion (Duopa) was evaluated in patients who had a mean
baseline “off” time of six hours while on an oral levodopa product and an adjunctive
medication [i.e. dopamine agonist, catechol-O-methyl transferase (COMT) inhibitor,
monoamine oxidase type B (MAO-B) inhibitor].
-
Evidence-based guidelines recommend the use of adjunctive therapies from various
classes, including dopamine agonists, COMT inhibitors, and MAO-B inhibitors for the
symptomatic control of motor fluctuations in patients experiencing “off” time while on an
oral levodopa product. [1,2]
-
The safety and efficacy of carbidopa/levodopa enteral infusion (Duopa) has not been
established in conditions other than advanced idiopathic PD.
Clinical Efficacy
-
One fair confidence trial demonstrated that carbidopa/levodopa enteral infusion (Duopa)
produces a modest reduction in “off” time relative to immediate release oral
carbidopa/levodopa in patients with advanced idiopathic PD. [3]
∗
Patients enrolled in this study had a mean baseline “off” time of six hours while
on a levodopa product AND an adjunctive medication from the dopamine agonist,
COMT inhibitor and/or MAO-B inhibitor class of medications. Mean difference in
“off” time was approximately 2 hours relative to immediate release
carbidopa/levodopa.
-
Carbidopa/levodopa enteral infusion (Duopa) has not been compared to any other
medication in the advanced PD setting.
-
A high quality Cochrane systematic review concluded that there is insufficient evidence
to demonstrate that one adjunctive therapy is clinically superior to another in terms of
reducing motor fluctuations or improving functional outcomes. Evidence is limited to
indirect comparisons of low to fair confidence placebo-controlled trials. [4]
Safety
-
The overall safety profile of carbidopa/levodopa enteral infusion (Duopa) significantly
lowers its net health benefit relative to existing alternatives.
∗
Carbidopa/levodopa enteral infusion (Duopa) is associated with a high rate (92%) of
clinically significant PEG-J tube related adverse events, some of which are serious
and/or life threatening and include intestinal hemorrhage, intestinal obstruction,
peritonitis, intestinal ischemia and post-operative wound infection. In addition, the
12-week duration of the pivotal trial may be insufficient to fully characterize the
long term safety of carbidopa/levodopa enteral infusion (Duopa). [3]
∗
In contrast, other oral and topical PD medications are generally well tolerated.
Common adverse events include drowsiness, nausea, vomiting, and hypotension.
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Dosing [5]
-
The maximum total daily dose of carbidopa/levodopa enteral infusion (Duopa) is 2000
mg of the levodopa component (i.e. one casette per day) administered over 16 hours.
Cassettes are for single use only and should not be used for longer than 16 hours.
Appendix 1: Dopamine agonists
apomorphine subcutaneous injection
ropinirole ER
bromocriptine mesylate
rotigotine transdermal patch (Neupro)
pramipexole
pramipexole ER
ropinirole
Codes
Number
Description
ICD-9
332.0
Idiopathic Parkinson’s disease
ICD-9
332.1
Secondary Parkinsonism
ICD-9
333.0
Atypical Parkinson’s disease
ICD-9
333.1
Essential and other specified forms of tremor
ICD-9
333.94
Restless leg syndrome
References
1.
Horstink, M, Tolosa, E, Bonuccelli, U, et al. Review of the therapeutic management of
Parkinson's disease. Report of a joint task force of the European Federation of
Neurological Societies (EFNS) and the Movement Disorder Society-European Section
(MDS-ES). Part II: late (complicated) Parkinson's disease. Eur J Neurol. 2006;13:1186202. PMID: 17038032
2.
Pahwa, R, Factor, SA, Lyons, KE, et al. Practice Parameter: treatment of Parkinson
disease with motor fluctuations and dyskinesia (an evidence-based review): report of the
Quality Standards Subcommittee of the American Academy of Neurology. Neurology.
2006 Apr 11;66(7):983-95. PMID: 16606909
3.
Olanow, CW, Kieburtz, K, Odin, P, et al. Continuous intrajejunal infusion of levodopacarbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised,
controlled, double-blind, double-dummy study. The Lancet Neurology. 2014
Feb;13(2):141-9. PMID: 24361112
4.
Stowe, R, Ives, N, Clarke, CE, et al. Evaluation of the efficacy and safety of adjuvant
treatment to levodopa therapy in Parkinson s disease patients with motor complications.
The Cochrane database of systematic reviews. 2010(7):CD007166. PMID: 20614454
5.
Duopa ™ [package insert]. North Chicago, IL AbbVie, Inc.; February 2016
© 2016. OmedaRx. All rights reserved.
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Revision History
Revision Date
Revision Summary
07/15/16
No criteria changes with this annual update
© 2016. OmedaRx. All rights reserved.
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